Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-19 are currently pending and an amendment to the claims filed on 06/25/2026 is acknowledged.
Withdrawn rejections:
Applicant's amendments and arguments filed 06/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejections --- as necessitated by amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-9, 13 and 15-18 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al., “Effect of sodium lauryl sulfate in dissolution media on dissolution of hard gelatin capsule shells”, Pharmaceutical Research, vol. 21, no. 1, January 2004.
Applicant claims the below claim 1 filed on 06/25/2026:
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Prior Art
Zhao discloses a gelatin capsule containing gelatin powder (see “Materials”, right column on page 144) and sodium lauryl sulfate (SLS) which is also solid (see “Introduction”, left column, first paragraph on page 144) which reads on the claimed solid composition, and even further, wherein the gelatin and SLS are isolated in the form of precipitate and then dried to obtain dried sample (see “Element Analysis”, right column on page 144) which also reads on the claimed solid composition. In the dissolution test of gelatin shell, the SLS surfactant reading on the claimed anionic surfactant having C12 alkyl chain moiety and sulfonic group slowed down dissolution rate in gelation capsule shell in which the capsule reads on the claimed film, and in particular, when Zhao investigated that sodium acetate or sodium phosphate buffer as a dissolution media reading on the claimed aqueous medium was used with or without SLS to cover the pH range of 1-7 (page 144 – right column), it was found that SLS interacts with gelatin to form a less-soluble precipitate at pH <5, and that is, the SLS significantly slowed down the dissolution of gelatin capsule shells at pH <5 due to decreased conformation stability of gelatin rather than the increased positive net charge, and on the other hand, the dissolution rate of gelatin shells at pH >5 (e.g., pH 5-8) is not decreased which reads on the claimed dissolution at pH 6.8 is higher than the dissolution rate at pH 1 (see abstract on right column page 144, left column and Fig.1 on page 145 and right column on page 147, and Conclusion, right column on page 148). Here, the instant pH range of 6.8 is within the pH range of 5-8 or pH>5 and the instant pH range of 1 is within the pH range of pH <5. (instant claims 1-2, 4, 6 and 9); Fig. 1 on page 145 shows effect of 1% SLS on the dissolution of hard gelatin capsule shells at 37C at pH 1 (=0.1N HCl) wherein 80% or less dissolution was within 60 minutes or 120 minutes embracing 70 or 90 minutes (instant claims 3 and 16); 30% w/w gelatin solution (type A or type B) and 1% SLS was used (left column, page 144); the SLS surfactant is sulfate ester (instant claim 7); the SLS has molecular weight of 288.38g/mol as evidenced by attached SLS Safety Data Sheet (see page 4) that is within the claimed range of 250-600g/mol (instant claim 8); the capsule is hard gelatin capsule shell that is seen as film (see entire document including abstract and conclusion) (instant claim 13); the shell film is the outer layer of the capsule (instant claim 15); according to Fig. 1, at 37C and at pH 1 (=0.1N HCl), the dissolution rate within 60 minutes embracing 20 or 30 minutes is 70% or less (see Fig. 1a on page 145) that is within the instant range of 50% or less or 80% or less and at 37C and at 37C and at pH 6.8, the dissolution rate within 45 minutes is 80 to less than 100% (see Fig. 1f on page 145) which is within the instant range of 50% or more (instant claims 17-18).
In light of the foregoing, instant claims 1-4, 6-9, 13 and 15-18 are anticipated by Zhao.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Zhao does not teach to include the SLS into the gelatin composition and instead Zhao introduces surfactant in the liquid system, not in a solid composition.
The Examiner responds that Zhao discloses a hard gelatin capsule shell comprising gelatin powder and SLS solid surfactant (see Introduction, left column, first paragraph and Materials, right column on page 144), which reads on the claimed solid composition; and even further, Zhao investigates dissolution rate of the hard gelatin capsule shell (see Dissolution method, right column on page 144) wherein a precipitate of gelatin solution and SLS is isolated and then dried to obtain dried sample (see Elemental Analysis: left column on page 144) which also reads on the claimed solid composition, and that is, the SLS is added to gelatin containing composition.
Accordingly, applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., “Effect of sodium lauryl sulfate in dissolution media on dissolution of hard gelatin capsule shells”, Pharmaceutical Research, vol. 21, no. 1, January 2004 as applied to instant claims 1-4, 6-9, 13 and 15-18 in view of Ahmad et al., (WO2017/095736A1).
Applicant claims the below claim 1 filed on 06/25/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Zhao was discussed above with respect to instant claims 1-4, 6-9, 13 and 15-18.
However, Zhao does not expressly teach 30-80% of gelatin amount and 8% or more of anionic surfactant of instant claims 5, 10 and 19; and plasticizer and its amount of instant claims 11-12, and encapsulating filling material comprising a food supplement or an active pharmaceutical ingredient of instant claim 14. The deficiencies are cured by Ahmad.
Ahmad discloses gelatin capsule containing aspirin, surfactant and plasticizer (see entire document including claims 1 and 8) wherein the capsule shell contains gelatin from about 10 to about 70% ([0012]) that overlaps the instant range of 20-80% MPEP 2144.05 noted above, and the surfactant includes SLS ([0013]-[0014]) and it is used in an amount of about 0.01 to about 10% ([0051]) that overlaps the instant range of 8% or more of instant claim 5 and 30% or less of instant claim 10. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claims 5, 10 and 19), and the plasticizer includes glycerol, sorbitol, propylene glycol, etc. ([0015] and claim 10 of prior art) and is used in an amount of about 10-about 30% ([0032]) that overlaps the instant range of 10-40% of instant claim 12. See MPEP 2144.05 above (instant claims 11-12); and the aspirin as a filling active pharmaceutical agent is encapsulated by gelatin shell (Fig. 1) (instant claim 14).
It would have been obvious to optimize the amounts of gelatin and surfactants of the applied art with the claimed amounts because the applied art teaches overlapping amounts and further increasing their amounts vary depending on the intended purpose, formulation type, relationship with other ingredients, etc., in the absence of criticality evidence of the claimed range.
Additionally, it would have been obvious to modify the teachings of Zhao with addition of plasticizer of Ahmad. One of the ordinary artisan would have been motivated to do so because added plasticizer would have enhanced properties of the gelatin capsule.
Further, it would have been obvious to modify the gelatin capsule by placing the filling material, e.g., active agent aspirin in the core of the capsule for oral administration to treat certain disorders and diseases, as taught by Ahmad.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Zhao relates to a hard gelatin capsule and Amed relates to a soft gelatin capsule; and the combination of those references would not result in the claimed invention because Zhao teaches to use SLS in the dissolution medium, and Ahmad teaches to include the surfactant in the capsule filing; and the applied art alone or in combination teaches a surfactant and gelatin in a gelatin composition.
The Examiner responds that the rejection does not rely on substituting Amad of soft gelatin capsule for Zhao’s hard gel capsule structure. Rather Amad is relied upon for its teachings of 30-80% of gelatin amount and 8% or more of anionic surfactant of instant claims 5, 10 and 19; and plasticizer and its amount of instant claims 11-12, and encapsulating filling material comprising a food supplement or an active pharmaceutical ingredient of instant claim 14; and further, Zhao provides the gelatin capsule and Amad provides the soft gelatin capsule, and that is, both references are directed to solid gelatin capsule type, and there is no evidence that Amad’s teaching concerning those features is limited to hard gelatin capsules. Thus, the mere disclosure of different capsule types does not negate the motivation to combine or the reasonable expectation of success. and it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981), and In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145; and Zhao teaches isolated precipitate of gelatin and surfactant SLS reading on the claimed solid composition, and final Zhao’s solid composition contains gelatin and SLS.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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